Morbid obesity is a chronic lifelong, multi-factorial disorder, causing the patient to have excessive fat deposits and associated medical, psychological, physical, social and economic problems. Obesity is directly correlated with type II diabetes and cardiovascular disease. Etiological factors include the involvement of hereditary, biochemical, hormonal, environmental, behavioral, health and cultural elements. Extreme forms of obesity are unlikely to respond to diet, behavioral therapy or medication alone. As early as 1991, the US National Institute of Health issued a statement recognizing the known lack of success with conservative forms of treatment, noting that operations to constrict or bypass the stomach were justified for fully informed and consenting patients and constituted an acceptable risk. Safe and effective surgical treatment increases the life expectancy and quality of life for some extremely obese individuals.
A variety of surgical procedures have been developed to treat obesity. For example, restrictive operations are performed, such as stomach stapling or gastric banding. In stomach stapling, an incision is made in the abdomen to gain access to the peritoneal cavity. Surgical staples and a plastic band are used to create a small pouch in the fundus region of the stomach. With gastric banding, a small band is placed just distal to the lower esophageal sphincter (LES), creating a small pouch. Alternatively, Roux-en-Y gastric bypass is commonly used. Gastric bypass surgery makes the stomach smaller and allows food to bypass part of the small intestine. Rarely used is a procedure called biliopancreatic diversion. Biliopancreatic diversion changes the normal process of digestion by making the stomach smaller and allowing food to bypass part of the small intestine so that fewer calories are absorbed.
These surgeries impart permanent changes to the patient's anatomy and are associated with a variety of complications. For example, chronic vomiting may occur after surgery. In gastric bypass, the stomach is connected to the bowel and the opening between them is made deliberately small to slow the flow of food out of the small stomach pouch. With healing, scar tissue forms which can sometimes cause further constriction. This may cause the opening between the stomach and the bowel to become so small that food cannot pass through, resulting in repeated vomiting. This complication can be corrected in an outpatient procedure during which the opening is stretched by a balloon inserted through a scope down into the stomach. If unsuccessful, a revisional surgery is required.
Such vomiting after surgery may cause a postoperative hernia. This is due to straining before the incision heals completely. Other causes are infections in the wound or body weight which pulls against the sutures. Hernias occur about 10% to 20% of the time after using a standard incision.
In addition, gastric bypass does not allow for normal absorption of iron, B-12 and calcium because the portion of the digestive system which absorbs these vitamins and minerals is bypassed. Deficiencies in these nutrients can lead to many problems. Iron deficiency causes anemia and weakness. Deficiencies in calcium can cause osteoporosis. Lack of daily B-12 can lead to neurological problems.
Further, patients may also develop bowel obstructions after surgery. Whenever two ends of an incision meet and are sewn together scar tissue forms. This scar tissue can cause adhesions which, in turn, can cause a bowel obstruction. This is a very serious condition that requires immediate attention.
Thus, it would be desired to provide less invasive treatments for obesity and other gastric disorders. Such treatments should avoid anatomical reconfigurations and their associated risks. In addition, such treatments should be capable of being tailored to the needs of the individual patient with few associated risks. At least some of these objectives will be met by the present invention.